Diffuse Large B-Cell Lymphoma
Conditions
Keywords
diffuse large B-cell lymphoma, MYC- and BCL2-positive, chidamide, zanubrutinib, lenalidomide, elderly patients
Brief summary
The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.
Interventions
DRUGCHiR-DEL
Using the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy.
Sponsors
First Affiliated Hospital of Ningbo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
： 1. Age ≥ 70 years; 2. ECOG score of 0-3; 3. Rated as unfit or frail on the simplified geriatric assessment (sGA); 4. Histologically confirmed CD20-positive diffuse large B-cell lymphoma (diagnostic criteria according to WHO 2016), excluding transformed type 2 DLBCL; 5. Immunohistochemically confirmed positive expression of MYC and BCL2 (MYC ≥ 40%, BCL2 ≥ 50% by immunohistochemistry); 6. Previously untreated patients; 7. Cardiac, hepatic, and renal function: creatinine \< 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 2.5 ULN; total bilirubin \< 2 ULN; 8. At least one measurable lesion; 9. Unable to tolerate standard CHOP regimen chemotherapy or unwilling to receive chemotherapy; 10. Adequate understanding and voluntary signing of the informed consent form.
Exclusion criteria
： 1.Patients with central nervous system involvement at the time of onset; 2.Known human immunodeficiency virus (HIV) infection; 3.Pregnant or lactating women; 4.Other tumors requiring treatment; 5.Uncontrollable active infection; 6.Active hepatitis with HBV-DNA copy number not controlled within 2\*1000/mL despite antiviral treatment; 7.Inability to understand, comply with the study protocol, or sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the complete remission rate (CRR) | Each cycle consists of 21 days, with a total of 8 cycles. | The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles. |
Countries
China
Contacts
Primary ContactLixia Chief Physician
Outcome results
None listed